Clinical Trials in Spain / NCT07042035
Recruiting
Observational
Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
NCT07042035 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Lung TrasplantLung Transplantation
Study summary
To evaluate, under usual clinical practice conditions and with a 12-month follow-up , the most relevant pharmacokinetic parameters of tacrolimus metabolism and safety, in patients with recent lung transplant (unilateral or bilateral) treated with LCPT.
Eligibility
Inclusion Criteria:
* Patients ≥18 years old.
* Patients who have received a first unilateral or bilateral lung transplant.
* Patients who have started oral treatment with tacrolimus using the LCPT formulation, with a once-daily dosage within the first 3 months post-transplant.
* Patients with a treatment duration expected to be ≥12 months.
* The patient (or their representative) can sign the informed consent to participate in the study.
Exclusion Criteria:
* Patients who have received a multi-organ transplant or have a history of any organ transplant, including lung.
* Patients with an estimated survival of \<12 months
* Patients diagnosed with cystic fibrosis
* Patients diagnosed with scleroderma.
* Patients diagnosed with a systemic disease affecting the digestive system.
* Patients in any situation or condition that, in the investigator's opinion, makes participation inadvisable, such as any treatment that may interfere with the study.
* Patients who are participating or have participated in an interventional research study within 30 days prior to inclusion.
* Pregnant women, those planning to become pregnant, or those who are breastfeeding.
* Patients who are unable to complete the study.
* Patients who have not signed the informed consent.
Primary outcome measure(s)
- To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety . — 1 year of follow up
Cmin Tacrolimus dose
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Chiesi España, Torre Realia BCN Plaza Europa 41-43 | L'Hospitalet de Llobregat | Barcelona | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07042035 on ClinicalTrials.gov ↗ ← All trials in Spain